Completed cleft and craniofacial research projects

In this study, physicians wanted to see what factors might influence patient outcomes for those children having two kinds of surgery, palatoplasty (repair of a cleft palate) and pharyngeal flap surgery for VPI (hypernasal speech caused by talking through the nose).

Number of patients in the study:

14 palatoplasty and 37 pharyngeal flap surgery patients

What physicians looked at:

This was a retrospective study, meaning that physicians analyzed data from previous surgeries. The doctors looked at: (1) whether the children had difficulty breathing immediately after surgery; and (2) whether the use of steroids or antibiotics affected how long patients needed to stay in the hospital.

Results:

Researchers found that the longer a mouth gag is held open during surgery, the greater the chance of swelling and difficulty in breathing. They also discovered that using steroids and antibiotics resulted in a shorter hospital stay (2.7 days with steroids compared to 4.2 days without, and 3.5 days when antibiotics were used instead of 4.0 days).

Recommendations:

The physicians conducting this study recommended that the surgical retractor used during these procedures be released periodically to improve post-operative breathing. They also decided that many other unidentified factors might have influenced the outcomes and thus recommended a prospective study (one that is designed beforehand for more control and uses randomization for better results).

This study is described in "Factors Influencing Palatoplasty and Pharyngeal Flap Surgery," by Craig W. Senders, M.D. and Max Fung, available from the Department of Otolaryngology, 2500 Stockton Boulevard, Sacramento, CA 95817.

Physicians conducted this research project in order to enhance the results obtained in the first study described above. This time, doctors wanted to see the effects of using perioperative steroids (i.e., steroids used before and after surgery) in children having palatoplasty (repair of a cleft palate).

Number of patients in the study:

20 palatoplasty patients. Half of the children received steroids before and after surgery, while the other half (the control group) did not.

What physicians looked at:

The doctors looked at whether the use of steroids would affect how long patients needed to stay in the hospital. This was a prospective, double-blind, randomized study (i.e., neither the doctors nor the patients knew which patients were given the steroids, and patients who received steroids were chosen at random). For this project, researchers collected data regarding one previously identified factor, steroids, using a controlled setting from which to draw their conclusions.

Results:

Researchers found that using steroids before and after surgery resulted in shorter hospital stays for these patients (1.5 days with steroids compared to 2.3 days without steroids).

Recommendations:

The physicians conducting this study recommended the use of steroids for this type of surgery, particularly in light of the importance of minimizing hospital stays and thereby decreasing health-care costs. (Note: A later study with a group of 45 patients found that using steroids produced less airway distress and less post-operative fevers, reinforcing a customary role for perioperative steroids in this kind of surgery.).

This study is described in "A Prospective, Double-Blind, Randomized Study of the Effects of Perioperative Steroids on Palatoplasty Patients," by Craig W. Senders, M.D., Brian E. Emery, M.D., Jonathan M. Sykes, M.D. and Hilary A Brodie, M.D., Ph.D., available from the Department of Otolaryngology, 2500 Stockton Boulevard, Sacramento, CA 95817.

This research project compared the use of the Furlow Palatoplasty technique and a UC Davis modification of this procedure with traditional palatoplasty methods. The Furlow Palatoplasty technique potentially improves soft palate function over traditional surgical techniques.

Number of patients in the study:

19 palatoplasty patients

What physicians looked at:

In this retrospective study (i.e., physicians analyzed data from previous surgeries), doctors compared the Furlow technique and UC Davis modification with traditional surgery, focusing on how much time it took for each kind of procedure and resulting patient complications under the UC Davis protocol. The Furlow technique is used for soft palate repair only, while the UC Davis modification is used on children with clefts that extend into the hard palate. The modified UC Davis procedure makes it easier for surgeons to repair the palate by using "relaxing incisions" that do not cause as much tension on the palate, allowing it to heal more easily. However, both techniques are more complicated that the traditional method.

Results:

Researchers found that the Furlow Palatoplasty and UC Davis modification took longer to perform than the traditional method (just under 1 hour more). In addition, there was greater blood loss using the newer procedures. In terms of healing, there were no fistulas (a hole between the nose and mouth) in any of the19 patients.

Recommendations:

The physicians conducting this study recommended that surgeons initially plan on using the traditional palatoplasty method. During the procedure, they should let the amount of blood loss determine whether or not they switch to the Furlow technique or the UC Davis modification. Surgeons must weigh the advantages of increased palate function from the newer procedures with increased operating time, the potential need for a blood transfusion, and other possible complications.

This study is described in "Modifications of the Furlow Palatoplasty (Six- and Seven-Flap Palatoplasties)," by Craig W. Senders, M.D. and Jonathan M. Sykes, M.D., available from the Department of Otolaryngology, 2500 Stockton Boulevard, Sacramento, CA 95817.

In this study, doctors were interested in seeing the effects of perioperative steroids (i.e., steroids used before and after surgery) for patients with VPI (hypernasal speech caused by talking through the nose).

Number of patients in the study:

18 pharyngeal flap surgery patients with a mean age of 11.3 years

What physicians looked at:

In this prospective, double-blind, randomized study (i.e., neither the doctors nor the patients knew which patients were given the steroids, and patients who received steroids were chosen at random), researchers looked at the length of hospitalization, incidence of fevers, length of time until a patient could drink easily and well, and airway problems.

Results:

Use of perioperative steroids did not show significant effects on any of the factors being studied. They did not change the length of hospitalization or affect the oral intake of fluid for these patients. No airway complications occurred in either the experimental or the control group.

Recommendations:

Because of the results, the use of steroids is not recommended for these patients. The fact that these children were older than patients studied in previous research projects may have affected the lack of significant benefits from steroids for this age group.

Physicians conducted this research project to compare lenient vs. traditional criteria used in determining when patients should be discharged from the hospital after surgery.

Number of patients in the study:

45 cleft palate repair patients.

What physicians looked at:

In this retrospective study (i.e., physicians analyzed data from previous surgeries), doctors compared two different hospital discharge criteria. Patients either had to be able to take in 60 percent of their ideal fluid per day (based on their weight and size) or 100 percent of their ideal fluid for one hour in order to be sent home.

Results:

Physicians found that 27 percent of the children had problems such as fevers or difficulty in drinking. These patients would have done poorly in the home environment had they been discharged early due to poor oral fluid intake or higher incidence of fevers. Although early discharge would have saved 16 hours of hospitalization per patient, it was determined that using lenient discharge criteria may jeopardize the quality of patient care.

Recommendations:

Doctors involved in this study recommend that patients having this type of surgery be kept in the hospital and discharged according to traditional criteria, despite the inclination to want to cut costs.

Publication of an article on this study is pending.

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